A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients With Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 335
- 试验地点
- 44
- 主要终点
- Number of Participants With SAEs With Lenvatinib
研究概览
简要总结
The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events [SAEs], grade 3 to 5 adverse events [AEs], dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with advanced or unresectable HCC for whom a decision has been made by the treating physician (at their discretion) to initiate lenvatinib or sorafenib treatment, within the prescribing conditions of the approved product label
- •Participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib
排除标准
- 未提供
研究组 & 干预措施
Lenvatinib
Participants with advanced or unresectable HCC will initiate treatment with lenvatinib capsules based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first.
干预措施: Lenvatinib (Drug)
Sorafenib
Participants with advanced or unresectable HCC will initiate treatment with sorafenib tablets based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first.
干预措施: Sorafenib (Drug)
结局指标
主要结局
Number of Participants With SAEs With Lenvatinib
时间窗: Up to 7 years
Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib
时间窗: Up to 7 years
Number of Participants With Grade 3 to 5 AEs With Lenvatinib
时间窗: Up to 7 years
AEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment with lenvatinib. AEs will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Here Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activity of daily living, Grade 4: life-threatening consequences; urgent intervention indicated and Grade 5: death related to AEs.
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib
时间窗: Up to 7 years
Number of participants with one or more TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib will be collected at the discretion of the treating physician and in accordance with the prescribing information.
次要结局
- Number of Participants With Hepatotoxicity TEAEs With Sorafenib(Up to 7 years)
- Number of Participants With SAEs With Sorafenib(Up to 7 years)
- Number of Participants With Grade 3 to 5 AEs With Sorafenib(Up to 7 years)
- Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib(Up to 7 years)
- Duration of Lenvatinib and Sorafenib Treatment(Up to 7 years)
- Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib(Up to 7 years)
- Relative Dose Intensity of Lenvatinib and Sorafenib(Up to 7 years)
- Number of Participants With Dose Interruption and Dose Reduction for Sorafenib(Up to 7 years)
- Overall Survival (OS) For Lenvatinib and Sorafenib(Up to 7 years)